Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD

ADHD Clinical Trial

Official title:

Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782080
• Other study ID #: Stei-Sed-0106
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2008
• Last updated: March 12, 2014
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2014
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

Study Design:

• Randomized

• Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

• Placebo Control

• Parallel Assignment

Description:

ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and atomoxetine naive patients. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

Participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8 weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side effects will be monitored continuously and also assessed by rating scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• DSM-IV Diagnosis of ADHD

• Score of ADHDRS-IV-Parent Version =24

• Sufficient knowledge of the German language

• Written Informed Consent by parents and patients

• Ability to swallow study medication

• Sexually mature and active adolescents with highly effective methods of birth control:

• contraception according to Pearl-Index < 1

• when use of oral contraceptives, additional methods of contraception (e.g. condoms) are necessary, i.e. double-barrier

Exclusion Criteria:

• Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients

• Known hypersensitivity of the skin when exposed to sunlight

• All serious internal diseases, and for this reason: Current intake of the following medication:

• Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment

• Irinotecan and other cytostatics

• anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptyline

• Midazolam, Theophylline or other medication with photosensitive effects

• All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason current intake of the following medication: antidepressants and other psychotropic medication

• Indication for hospitalization

• Suicidality (including suicidal thoughts): Score =3 in item 10 of MADRS

• Pregnancy, lactation

• IQ < 70

• Positive screening for metabolites of illegal drugs in urine

• Previous medication with stimulants and/or atomoxetine

• Psychotropic co-medication

• Placement in an institution on official or judicial ruling

• Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago

• Patients requiring a primary medication with methylphenidate during the study period of 8 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Sedariston
St. John´s Wort (100 mg) Valerian Extract (50 mg)
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Rheinhessenfachklinik	Alzey
Germany	DRK Fachklinik für Kinder- und Jugendpsychiatrie	Bad Neuenahr
Germany	Charité University	Berlin
Germany	Praxis für Kinder- und Jugendpsychiatrie	Berlin
Germany	Johannes Gutenberg University	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Huss	Steiner Arzneimittel, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-IV rating scale		Difference in total score between baseline and end of study	No
Secondary	Barkley´s Side Effects Rating Scale		Difference between baseline and each visit	Yes